1. Field of the Invention
The present invention relates to a disposable intraluminal ultrasonic instrument which includes a catheter that has an ulterasonic sound wave transducer therein and a rotatable acoustic mirror for directing the sound waves outwardly into tissue and for receiving echo sounds and directing the echo sounds to the transducer for transmission to a visual display which displays an ultrasound picture of the tissue whereby one can determine the makeup or construction of the tissue, e.g., hard or soft. The present invention also relates to a micro motor used in such an instrument for rotating the acoustic mirror while the transducer provides sound waves to the acoustic mirror.
2. Description of the related art including information disclosed under 37 CFR Sections 1,97-1.99
Heretofore it has been proposed in Dutch Patent Application No. 87.00632 to provide a catheter having a catheter tip with a rotatable acoustic mirror therein or a rotatable tip having an acoustic mirror therein. A flexible shaft extends from the rotatable acoustic mirror to the proximal end of the catheter where it is driven by a suitable motor situated outside the catheter. A transducer is mounted in the catheter tip opposite the rotatable acoustic mirror. Rotation of the acoustic mirror within the tip of the tip portion having the mirror thereon causes high frequency ultrasonic vibrations or sound waves emitted by the transducer to be emitted in different directions in a rotating path and the echoes of the sound waves are received by the acoustic mirror and thence by the transducer for transmission to a visual display whereby a picture can be created cf the space around the catheter tip which may contain tissue or a stenotic buildup in a vessel.
A problem with the instrument having the catheter described above is that the flexible drive shaft is fairly long, i.e., at least as long as the catheter itself. With this arrangement, it is difficult to supply a torsion free rotational force through the flexible drive shaft and to drive such a long flexible drive shaft for extended periods of time without malfunctioning.
As will be described in greater detail below, the present invention provides an intra-luminal ultrasonic instrument which does not have the problem of a long drive shaft by providing a micro motor of very small diameter in the catheter tip for driving a short drive shaft coupled to an acoustic mirror in the catheter tip, the motor having flat stator coils mounted on a flexible circuit board.
It has been suggested in Dutch Patent Application No. 87.00632 to provide a turbine driven by fluid at or near the catheter tip with the turbine having a short drive shaft coupled to the rotatable acoustic mirror.
Heretofore it has been proposed in European Patent Application Publication No. 0 139 574 to provide an endocavity probe having a motor mounted in the distal end of one embodiment of the probe. The motor rotates a mirror which reflects signals emitted by a transducer.
This probe is utilized in examining organs and the like of a body. The probe is somewhat bulky in shape any size, is intended for insertion in body cavities, is not suitable for insertion inside veins and/or arteries and does not teach a motor having stator coils mounted on a flexible circuit board and having a diameter no greater than 3 millimeters mounted in a catheter tip.
In the Sakai German Offenlegungsschrift DE 32 19 118 A1 there is disclosed an endoscope having a metal housing in which is mounted a rotatable mirror and a motor for rotating the mirror. Also, fiber optics are provided for viewing capabilities. This patent publication does not disclose or suggest a catheter tip no greater than 3 millimeters in diameter having a micro motor mounted therein for rotating an acoustic mirror positioned adjacent to a transducer in the catheter tip.
The Eggleton et al. U.S. Pat. No. 4,546,771 discloses an acoustic microscope which has a transducer capable of producing and receiving high frequency acoustical beams and is positioned within a needle. This patent teaches using frequencies of 100 megahertz to 400 megahertz, and preferably frequencies of 500 megahertz or greater. These frequencies do not produce the necessary depth obtained with frequencies under 60 megahertz as utilized in the ultrasonic instrument of the present invention.
This patent teaches the rotation of a rotating member by an arrangement of small electromagnets and permanent magnets attached to a needle. The needle in this patent can only be inserted into tissue for biopsy procedures and is not adapted to be inserted into a blood vessel, nor is it intended to be inserted into a blood vessel like the catheter tip of the present invention for evaluating space around the catheter tip and particularly, the tissue or stenotic buildup located around the catheter tip to a sufficient depth.
A number of ultrasonic instruments for the examination and/or treatment of blood vessels have been previously proposed. Examples of these previously proposed instruments are disclosed in the following United States Patents, the disclosures of which are incorporated herein by reference:
______________________________________ Patentee U.S. Pat. No. ______________________________________ Yock 4,794,931 Pope et al 4,889,757 Prodian et al 4,917,097 Yock 5,000,185 Lum et al 5,003,238 Passafaro 5,010,886 Yock et al 5,029,588 ______________________________________
A miniature stepper motor for use in timepiece is disclosed in the Knapen et al U.S. Pat. No. 4,908,808 assigned to Kinetron, B.V., The Netherlands.
According to the present invention there is provided a disposable intra-luminal ultrasonic instrument comprising: a catheter having an elongate axis and a hollow distal end portion; an acoustical mirror face; structure for mounting the acoustical mirror face for rotation in the distal end portion of the catheter with the acoustical mirror face arranged at an angle to the elongate axis of the catheter; a transducer; structure for mounting the transducer in the distal end portion of the catheter in a position to propagate acoustic waves toward the acoustical mirror face; a micromotor having a length no greater than approximately 6 millimeters and a diameter no greater than approximately 2.4 millimeters; structure for mounting the micromotor in the distal end portion of the catheter; structure for connecting the micromotor to the acoustical mirror face; conductors for connecting the micromotor to a source of energy for energizing the micromotor to rotate the acoustical mirror face; and, conductors for connecting the transducer to a source of energy for energizing the transducer to produce and supply sound waves to the rotatable acoustical mirror face.